09:04 AM EDT, 10/15/2024 (MT Newswires) -- Amgen ( AMGN ) said Tuesday that the phase 3 trial assessing the efficacy and safety of Uplizna in adults with the autoimmune disorder generalized myasthenia gravis met its primary endpoint.

The company said a "statistically significant change" from baseline in myasthenia gravis activities of daily living score was observed for Uplizna compared with placebo for the combined study population at week 26.

Amgen ( AMGN ) also said that for the first four key secondary endpoints, Uplizna showed a "statistically significant and clinically meaningful change" from baseline compared with placebo at week 26.

The company added that the overall safety results during the trial's placebo-controlled period were consistent with Uplizna's known safety profile.

Uplizna is currently approved in the US, European Union, Canada and Brazil as a treatment for neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 antibody positive.

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